Device for regulating physiological temperature and method of using same

Abstract

A wearable cooling device (10, 36) for cooling the temperature of an external genital region of a subject is described. In an embodiment, the apparatus comprises: an air delivery portion (16) configured for fitting around the genital region; and at least one motorized fan (18) arranged for flowing air to the air delivery portion (16) by using the fan in contact with the genital region to cool the genital region. Embodiments may further include a duct (12, 14) for directing the air to the air delivery portion; at least one temperature sensor (28); and a control system (26) for controlling operation of the fan in response to the measured temperature. The invention also describes a use method of the cooling device. The cooling device is particularly suitable for cooling the testis of a male subject to enhance the fertility of the subject.

Description

Technical Field

[0001] This invention relates to an apparatus and method for regulating the temperature of the genital region of a male or female subject. In a particularly preferred embodiment, the apparatus as described herein is suitable for regulating the temperature of the testes of a male subject to improve the subject's fertility and / or other fertility-related physiological outcomes. Background Technology

[0002] Batists or cricketers typically wear genital protectors inside their underwear when playing cricket or baseball to protect their genital area and minimize the risk of injury from being hit by the ball. Hockey players may also wear similar protectors to reduce the risk of injury from being hit by a hockey ball or ice hockey puck (especially in ice hockey). These protectors usually consist of a hard plastic cup (also known as a "box" in cricket) designed to cover the genitals. However, wearing a plastic cup can be uncomfortable due to heat buildup in the genital area. This is especially true for cricket batters, who may spend long periods on the cricket pitch in hot weather.

[0003] For men, elevated temperature in the genital region (particularly the testes) may be associated with decreased fertility. More specifically, testicular temperature is typically lower than core body temperature, and elevated testicular temperature can adversely affect fertility. For example, semen parameters, including but not limited to sperm count, may decrease. Normal sperm development may also be adversely affected, leading to abnormal sperm morphology and / or sperm motility. Both testicular germ cells and epididymal sperm are sensitive to elevated testicular temperature, which may be caused by hyperthermia or a sharp increase in the ambient temperature of the genital region. In addition to impaired forward sperm motility, the temperature elevation effect can also adversely affect sperm viability, cell concentration, semen volume, and semen pH. Furthermore, hyperthermia in the scrotum may lead to or exacerbate sperm DNA breakage and / or DNA damage. In summary, elevated testicular temperature can have a significant adverse effect on sperm function and fertilization capacity, and on semen quality.

[0004] To naturally regulate temperature, the testicles of human males are positioned relatively offset from each other, with the left testicle typically hanging down in the scrotum, lower than the other. However, exposure to high temperatures or hot climates, or engaging in sports such as cricket, baseball, or hockey as described above, wearing tight underwear, prolonged sitting at a desk in modern workplaces, driving or operating a vehicle, and obesity, and even a sedentary lifestyle, can impair this natural temperature regulation of the testicles. Elevated testicular temperature, which adversely affects male fertility, can also be caused by varicocele, a testicular pathology in which blood pools in dilated veins in the scrotum. Cryptorchidism, in which the testicle fails to descend, can also cause elevated testicular temperature. In some men, elevated testicular temperature is inherently idiopathic and has no identified associated pathology.

[0005] For example, cooling bags have been used to treat or mitigate the adverse effects of elevated testicular temperature on male fertility. For instance, a product previously offered under the brand name UNDERDOG... TM The device, sold by Underdog Fertility (Orangeville, Ontario, Canada), consists of a wedge-shaped ice pack inserted into a soft sleeve. To use the device, the cooled ice pack is inserted into the sleeve and slid between the subject's legs while the subject is seated, placing the device under the subject's testicles. Cooling of the testicles is achieved through the subject's pants while the subject remains seated. Another known system is marketed under the brand name SNOWBALLS. TM Sold by Under Ice LLC, Richmond, Virginia, USA. This system requires inserting a cooling bag / ice pack into a pocket placed in the subject's underwear, positioning the ice pack to cool the subject's testicles. However, a significant drawback of this type of system is that the cooling effect depends on whether the cooling bag remains cold, and therefore its use is limited by the duration the cooling bag remains cold. Furthermore, testicular cooling depends directly on heat transfer through the subject's clothing, which carries the potential for significant discomfort due to overcooling. Additionally, this type of device lacks temperature control functionality.

[0006] Another one is under the brand name CoolMen TM The system being sold (Cooltec Sp. Zou, Wrocław, Poland) is a lightweight device designed to promote sperm production. To use it, the user places a cup around the scrotum. A battery-powered Peltier cooling system then cools the area around the scrotum. However, the Peltier device generates heat, which must be dissipated from the scrotal area.

[0007] There is a need for an improved device for controlling the temperature of the genital areas of men and women, or at least an alternative device for this purpose. Summary of the Invention

[0008] Generally, the present invention relates to a device for regulating the temperature of the genital area of ​​a male or female subject.

[0009] More specifically, in one aspect of the invention, a wearable cooling device is provided for regulating the temperature of a subject's external genitalia region, the device comprising:

[0010] An air delivery section configured for assembly around the genital area; and

[0011] At least one electric fan is arranged to allow air to flow to the air delivery section by the operation of the fan, so that the air comes into contact with the genital area to cool the genital area.

[0012] Typically, at least one fan is arranged to direct air from outside the underwear to the subject's genital area, which the subject wears inside the underwear when using the cooling device.

[0013] Typically, cooling devices include pipes for directing airflow to the genital area.

[0014] On the other hand, the present invention relates to a wearable cooling device for regulating the temperature of a subject's external genitalia region, the device comprising:

[0015] A conduit used to direct airflow to the genital area;

[0016] At least one electric fan, arranged to direct air along a duct to contact the genital area by the operation of the fan; and

[0017] A control system that can be operated to control the operation of the fan.

[0018] Typically, in the embodiments described herein, the conduit directs airflow from the fan to the delivery section, and the conduit leads into the air delivery section so that the airflow comes into contact with the genital area.

[0019] Typically, the cooling device will further include at least one temperature sensor for measuring the temperature of the genital area or its vicinity.

[0020] Typically, the control system of this device is operable to control the operation of the fan in response to the temperature measured by at least one temperature sensor.

[0021] Therefore, another aspect of the present invention relates to a wearable cooling device for regulating the temperature of a subject's external genital region, the device comprising:

[0022] A duct used to direct airflow to the genital area;

[0023] At least one electric fan is arranged to direct air along a duct to contact the genital area by the operation of the fan;

[0024] At least one temperature sensor for measuring the temperature of the genital area or its vicinity; and

[0025] A control system operable to control the operation of a fan in response to a temperature measured by at least one temperature sensor.

[0026] Typically, the control system can be operated to control the operation of the fan to suppress the measured temperature rise or to cool the genital area.

[0027] Typically, at least one fan is operated to lower the temperature of the genital area, and most preferably, the temperature of the genital area is lowered to a predetermined temperature.

[0028] In a particularly preferred embodiment, at least one fan is operated to maintain the temperature of the genital area at a predetermined temperature.

[0029] In the embodiments described herein, the airflow flowing to the subject's genital area can achieve evaporative cooling of the genital area and / or heat transfer from the genital area.

[0030] In at least some embodiments, at least one fan is located inside the duct to direct airflow along the duct to the genital area, although the fan can be arranged in any suitable manner to achieve airflow through the duct to the genital area. In other embodiments, at least one fan is mounted outside the duct to allow air to flow through the duct to the air delivery section to contact the genital area.

[0031] In a particularly preferred embodiment, the device is configured to draw in air from above the subject's trouser height via the operation of a fan, causing airflow to the air delivery section. Typically, in these embodiments, the opening of the duct is at or above the trouser height to allow air to flow into the duct.

[0032] In other embodiments, the device is configured to draw in air at groin height outside the subject's underwear via the operation of a fan, causing the air to flow to an air delivery section. Typically, in these embodiments, a conduit is arranged to allow air to flow into the conduit at groin height.

[0033] In a particularly preferred embodiment, the air delivery portion is configured for mounting on the genital area.

[0034] Most commonly, the shape of the air delivery section is designed to cover the subject's genital area when the subject wears the device.

[0035] Typically, in embodiments where at least one temperature sensor is provided as described above, the temperature sensor is mounted on the air delivery section facing the genital area for measuring temperature.

[0036] In another aspect of the invention, a wearable cooling device is provided for regulating the temperature of a subject's external genitalia region, the device comprising:

[0037] At least one electric fan is arranged to direct airflow to the genital area through the operation of the fan;

[0038] At least one temperature sensor for measuring the temperature of the genital area or its vicinity; and

[0039] A control system that is operable to control the operation of the fan in response to the temperature measured by a temperature sensor.

[0040] In another aspect of the invention, a wearable cooling device is provided for regulating the temperature of a subject's external genitalia region, the device comprising:

[0041] An air delivery section, which is assembled around the genital area, is used to deliver air to contact the genital area;

[0042] At least one electric fan, arranged to direct airflow to an air delivery section by the operation of the fan; and

[0043] A control system that can be operated to control the operation of the fan.

[0044] Typically, at least one fan is operable to start or increase the airflow to the genital area when the measured temperature is higher than a predetermined temperature, and to reduce or stop the airflow to the genital area when the measured temperature decreases or approaches, reaches or falls below a predetermined temperature.

[0045] In a particularly preferred embodiment, the device includes a plurality of the temperature sensors, and the fan is operable to start or increase the airflow to the genital area when the temperature measured by at least one sensor is higher than a predetermined temperature, and to reduce or stop the airflow to the genital area when the temperature measured by at least one sensor decreases or the measured temperature approaches, reaches or falls below the predetermined temperature.

[0046] In an embodiment, the initiation, cessation, increase, and / or decrease of the airflow toward the genital area can be controlled by the temperature measured by the same temperature sensor or different temperature sensors in the temperature sensor suite.

[0047] Embodiments of the cooling device according to the invention may further include a humidity sensor for measuring humidity in the vicinity of the genital area. As described herein, the measured humidity can be used to provide data for assessing heat stress and the relevant operation of the cooling device's fan.

[0048] Typically, in embodiments including a humidity sensor, at least one fan is operable to activate or increase the airflow toward the genital area when the temperature measured by at least one temperature sensor is above a predetermined temperature, and the speed of the fan is controlled by the device's control system to correlate with the humidity or humidity level measured by the humidity sensor near the genital area.

[0049] Typically, the device includes multiple fans to direct airflow to the subject's genital area.

[0050] The conduit as described in the embodiments herein may include a first conduit and a second conduit for directing airflow to the genital region. In at least some embodiments, the first and second conduits are arranged at an angle such that when a subject wears the device, the conduits converge toward each other in a direction toward the genital region, and each of the first and second conduits is arranged to direct airflow to the genital region under the action of at least one fan. In such embodiments, the device may include a corresponding fan arranged to direct airflow to the genital region through a corresponding conduit.

[0051] In at least some embodiments according to this disclosure, the temperature measured by at least one temperature sensor may be the surface temperature of the genital region. In such embodiments, the temperature sensor or each temperature sensor is typically an infrared temperature sensor. Most commonly, in these embodiments, at least one temperature sensor is arranged to measure the temperature at or around the middle region of the genital region in a top-to-bottom direction.

[0052] In other embodiments, and as described above, a temperature sensor can be used to measure the temperature near the genital area. Sensors that can be used for this purpose include environmental sensors, which include the temperature sensor and humidity sensor described above.

[0053] Furthermore, the cooling device embodied in this invention may include at least one additional temperature sensor for measuring the temperature of the genital area (e.g., ambient temperature or surface temperature). In embodiments where an additional such temperature sensor is provided, the temperature measured by the additional sensor may be used as a reference temperature for controlling the operation of the fan, and / or as a fail-safe temperature measurement for continued operation of the cooling device in the event of a failure of the aforementioned main temperature sensor (e.g., an infrared sensor) or other temperature sensors or their associated circuitry. The additional temperature sensor may be used to measure the temperature when placed in contact with or near the genital area (such as, for example, the scrotal neck of a male subject). The additional temperature sensor may be, for example, a thermistor, infrared, or other temperature-sensitive sensor.

[0054] Typically, when the subject is male, the genital area is the subject's scrotum.

[0055] In such embodiments, most commonly, the device is configured to regulate the temperature of a male subject's testicles by cooling the surface of the subject's scrotum.

[0056] Therefore, another aspect of the present invention relates to a wearable cooling device for regulating the temperature of the testicles of a male subject, the device comprising: a conduit for directing airflow to the scrotum of the subject; at least one electric fan arranged to allow airflow along the conduit to contact the scrotum of the subject by means of fan operation; at least one temperature sensor for measuring the temperature of the scrotum or its vicinity; and a control system operable to control the operation of the fan in response to the temperature of the surface of the scrotum measured by the at least one temperature sensor.

[0057] The cooling device according to the invention may further include a power source for providing power for the operation of the device. Alternatively, the device may be connected to an external power source for operating the device. The power source may be, for example, a rechargeable battery.

[0058] Regardless of whether the device described herein is for male or female wear, the predetermined temperature is typically a temperature at which the subject feels comfortable. Generally, for men, the predetermined temperature is used to lower and / or maintain the temperature of the testicles below the subject's core body temperature.

[0059] In the embodiments described herein, the predetermined temperature may include temperatures within a predetermined temperature range. For male subjects, this temperature range may be about 29°C or lower to about 34°C or 35°C, including the extreme values.

[0060] In another aspect of the invention, a method for cooling the temperature of a subject's external genitalia region is provided, the method comprising:

[0061] A wearable cooling device is provided for a subject to wear to cool the genital area. The cooling device includes: an air delivery section for mounting around the genital area to deliver an airflow into contact with the genital area; at least one electric fan arranged to allow ambient airflow to the air delivery section by the operation of the fan; and a control system operable to control the operation of the fan.

[0062] The device was fitted to the subject; and

[0063] When the subject wears the device, they operate the device's control system to run a fan, causing air to flow to the air delivery section.

[0064] In another aspect of the invention, a method for cooling the external genital region of a subject is provided, the method comprising:

[0065] A wearable cooling device is provided for a subject to wear to cool the genital area. The cooling device includes: a conduit for directing airflow to the genital area; at least one electric fan arranged to direct airflow along the conduit to contact the genital area by the operation of the fan; and a control system operable to control the operation of the fan.

[0066] The device was fitted to the subject; and

[0067] When the subject wears the device, they operate the device's control system to run a fan so that air flows to the genital area.

[0068] In another aspect of the present invention, a method for regulating the temperature of a subject's external genitalia region is provided, the method comprising:

[0069] A wearable cooling device is provided for a subject to wear to cool the genital area. The cooling device includes: a conduit for directing airflow to the genital area; at least one electric fan arranged to direct airflow along the conduit to contact the genital area by the operation of the fan; at least one temperature sensor for measuring the temperature of the genital area or its vicinity; and a control system operable to control the operation of the fan.

[0070] The device was fitted to the subject; and

[0071] When the subject wears the device, the device's control system operates in response to the temperature measured by at least one temperature sensor to control the operation of the fan.

[0072] In another aspect of the present invention, a method for regulating the temperature of a subject's external genitalia region is provided, the method comprising:

[0073] A wearable cooling device is provided for a subject to wear to cool the subject's genital area. The cooling device includes: at least one electric fan arranged to direct airflow to contact the genital area by the operation of the fan; at least one temperature sensor for measuring the temperature of the genital area; and a control system operable to control the operation of the fan in response to the temperature of the genital area measured by the temperature sensor.

[0074] The device was fitted to the subject; and

[0075] When the subject wears the device, the control system of the device controls the operation of the fan in response to the temperature of the surface of the genital area measured by at least one temperature sensor.

[0076] In another aspect of the invention, a method for regulating the temperature of the testes of a male subject is provided, the method comprising:

[0077] A wearable cooling device is provided for a subject to wear to cool the surface temperature of the subject's scrotum. The cooling device includes: a conduit for directing airflow to the scrotum; at least one electric fan arranged to direct airflow along the conduit to contact the subject's scrotum by the operation of the fan; at least one temperature sensor for measuring the surface temperature of the scrotum; and a control system operable to control the operation of the fan.

[0078] The device was fitted to the subject; and

[0079] When the subject wears the device, the control system of the device controls the operation of the fan in response to the temperature of the scrotum surface measured by at least one temperature sensor.

[0080] In another aspect of the invention, a method for regulating the temperature of the testes of a male subject is provided, the method comprising:

[0081] A wearable device is fitted to a subject to cool the surface temperature of the subject's scrotum. The cooling device includes: a conduit for directing ambient air to the scrotum; at least one electric fan arranged to direct air along the conduit to contact the subject's scrotum via fan operation; at least one temperature sensor for measuring the surface temperature of the scrotum; and a control system operable to control the operation of the fan; and

[0082] When the subject wears the device, the control system of the device controls the operation of the fan in response to the temperature of the scrotum surface measured by at least one temperature sensor.

[0083] To facilitate athletes wearing the device according to this disclosure while performing their chosen sport (such as cricket, baseball, hockey, or ice hockey, or any other sport that may expose the genital area to contact injury), the device described herein can be incorporated into a genital protector. In this case, the device's conduit can lead to the genital protector, and when the device is installed, at least one temperature sensor of the device can be positioned to measure the temperature of the genital area below or near the genital protector. Alternatively, for example, in at least some embodiments, the air delivery portion of the device can be configured and sized as needed to act as a genital protector to protect the subject from impact injuries to the genital area.

[0084] In one form of the cooling device described herein, a fan may be configured to provide comfort to the subject without monitoring the temperature of the genital area. In practice, in embodiments of the cooling device according to this disclosure, the device may not include any temperature sensors for measuring the temperature of the genital area or its vicinity, and the control system of such embodiments may include or consist of a switch disposed on the device itself for the user to manually turn the fan on or off as needed.

[0085] In other embodiments, operation of the cooling device according to the invention can be achieved via a wireless connection to the cooling device using a software application (app) installed on a smartphone, tablet, computer, or other suitable electronic device. In embodiments, the application may allow the subject / user to remotely operate the device of the invention. In a particularly preferred embodiment, the application may provide one or more of the following: for example, turning the device on and off; setting a specific predetermined temperature or predetermined temperature range to cause the device to operate automatically; and monitoring one or more parameters, which may be selected from ambient air temperature, currently measured temperature of the genital area or its vicinity, or, in the case of a male, the surface temperature of the scrotum or estimated temperature of the testes, the change of measured temperature over time, the current usage duration of the device, the power level of the device's power supply, the remaining available usage time, the setting of a timer for the device's operation, and / or the remaining or elapsed time of the timer. The application may also include a usage log, allowing the user / subject to view relevant usage data, such as measured temperature and the change of measured temperature over time, as well as the time and date of use.

[0086] Therefore, in another aspect of this disclosure, an apparatus embodied in the present invention is provided, which is combined with a portable electronic device programmed to control the operation of the apparatus, and most commonly, to display and / or store data and / or one or more measured parameters or operating parameters of the apparatus.

[0087] In another aspect, a portable electronic device is provided, which is programmed to control the operation of the cooling device embodied in the present invention, and most commonly, to display and / or store data and / or one or more measured parameters or operating parameters of the device.

[0088] Portable electronic devices are typically configured to connect wirelessly to cooling devices.

[0089] Typically, the control system of the cooling device embodied in this invention includes a microcontroller for controlling the operation of at least one fan of the device. In a particularly preferred embodiment, the microcontroller is configured to operate the fan in response to a temperature measured by at least one temperature sensor.

[0090] In embodiments where a humidity sensor is provided for measuring humidity near the subject's genital area, the microcontroller can be configured to control the operation of at least one fan based on output data from a temperature sensor and / or a humidity sensor. In embodiments including a humidity sensor, the operation of the fan can be controlled by the microcontroller based on the temperature and humidity measured by the temperature and humidity sensors.

[0091] In the latter case, where the microcontroller operates the fan based on output data from both the temperature and humidity sensors, the microcontroller can be configured to control fan operation according to a pre-programmed Temperature Humidity Index (HTI). Typically, in such embodiments, the microcontroller is configured to cause at least one fan to operate at a speed correlated with the humidity measured by the humidity sensor.

[0092] In such embodiments, most commonly, the microcontroller is configured to operate at least one fan at one or more progressively increasing speeds, each of which is correlated with progressively increasing humidity as measured by a humidity sensor.

[0093] In a particularly preferred embodiment, the cooling device is configured to operate wirelessly via a software application (app) installed on an electronic device (e.g., a smartphone or other portable electronic device).

[0094] Typically, humidity sensors are used to measure the relative humidity near the genital area of ​​a subject.

[0095] Typically, the control system of the cooling device further includes a wireless connectivity module configured to interface with the microcontroller of the control system for wireless connectivity between the device's control system and the application.

[0096] Most commonly, the wireless connectivity module is a Bluetooth module used for communication between the cooling device and the application. TM Connected Bluetooth TM It can be a module, but any other suitable wireless connectivity module can also be used.

[0097] In other embodiments, the apparatus as described herein can be configured to receive a removable data storage device (e.g., a removable memory card) for recording data generated using the apparatus as described above, so that the data can be later downloaded from the storage device and viewed on an external digital device (e.g., a computer).

[0098] In yet another embodiment, the present invention provides an apparatus for cooling and / or regulating the temperature of a subject's genital area as described herein, the apparatus being programmed or programmable to control the operation of the apparatus to influence the cooling and / or regulation of the temperature of the genital area.

[0099] When a predetermined temperature in the genital area is achieved using the device as described herein, the operation of one or more fans of the device may be stopped, or operated to reduce the airflow through the duct to the genital area to only a certain percentage of the normal airflow obtained by the fans. The fans may also operate intermittently to maintain the surface temperature of the genital area at or within a predetermined temperature range. This may include the fans operating as needed at partial speed, normal speed, or a combination of the foregoing to maintain or achieve the desired airflow and / or predetermined temperature.

[0100] The cooling device of the embodiments of the invention described herein can be inserted into the front of the subject's underwear and held in place by the underwear when the subject wears the device. In a particularly preferred embodiment, the device can be inserted into a pocket provided in the underwear or other undergarments to hold the device in place within the pocket. Alternatively, a belt and / or waistband can be used with the cooling device to help hold the device in place.

[0101] One or more sensors used to measure the temperature of the genital area or its vicinity are typically located within the line of sight of the genital area. If the device is located in a pocket of the subject's underwear, the pocket may contain mesh or other suitable separating layers to prevent direct contact between the sensors and the genital area, while still allowing temperature measurement via the temperature sensors.

[0102] The device according to the invention is suitable for regulating the temperature of the testes of a male subject to achieve one or more outcomes, which may be selected, for example, from the group consisting of: treatment or prevention of heat-induced infertility, low fertility, testicular hyperthermia and / or sperm morphological abnormalities caused by testicular hyperthermia or elevated testicular temperature, treatment or prevention of sperm DNA breakage, increase in sperm count, improvement or enhancement of sperm progression or other sperm motility, improvement in sperm viability, and improvement in semen and / or seminal plasma quality. Therefore, the device and method described herein can be used to treat or improve various aspects of male infertility or low fertility, and / or aspects related to achieving successful pregnancy.

[0103] Advantageously, in one or more embodiments of the device according to the invention, the device provides ease of use and controls and regulates the temperature of the genital area within a desired predetermined temperature range. Since the subject can wear the device while it is in operation, in at least some embodiments, the subject can engage in sports, continue working, or otherwise perform their normal daily activities while wearing the device. It is also advantageous that the device as described herein can be provided in a thin or relatively inconspicuous design or configuration. Furthermore, power consumption can be saved by operating the fan of the device in a stop / start manner and / or by controlling the speed of the fan as described herein, thereby allowing for extended operating time of the device. Additionally, using the device according to this disclosure avoids the use of Peltier coolers and cooling bags / ice packs, and the limitations and disadvantages associated with using such cooling systems.

[0104] In the context of the temperature of the subject’s genital area or testes, the term “regulating” and its alternative forms, such as “regulate” and “regulation”, as used herein, should be understood in its broadest sense, including controlling the temperature of the genital area, lowering the temperature of the genital area, and / or inhibiting the rise in temperature of the genital area, whether in response to the measured temperature or the setting or programmed operating parameters or functions of the cooling device.

[0105] Throughout this specification, the word “comprise” or variations thereof (such as “comprises” or “comprising”) shall be understood to imply inclusion of the stated element, integer or step, or group of elements, integers or steps, but does not exclude any other element, integer or step, or group of elements, integers, integers or steps.

[0106] Any discussion of literature, actions, materials, devices, articles of manufacture, etc., included in this specification is for the purpose of providing context for the invention only. It should not be construed as an admission that any or all of these matters form part of the prior art or are common general knowledge in the field related to the invention, as they existed in Australia or elsewhere prior to the priority date of this application.

[0107] The features and advantages of the present invention will become apparent from the following detailed description of exemplary embodiments of the invention and from the accompanying drawings. In at least some embodiments, common components or features may be identified using the same designations for ease of description. Attached Figure Description

[0108] Figure 1 This is a front view of the wearable cooling device embodied in this invention;

[0109] Figure 2 yes Figure 1 An isometric rear view of the cooling device;

[0110] Figure 3 yes Figure 2 A top view of the cooling device;

[0111] Figure 4 yes Figure 3 A bottom view of the cooling device;

[0112] Figure 5 This is a front view of another embodiment of the cooling device embodied in the present invention;

[0113] Figure 6 yes Figure 5 Rear view of the cooling device;

[0114] Figure 7 yes Figure 6 Side view of the cooling device;

[0115] Figure 8 yes Figure 7 A top view of the cooling device;

[0116] Figure 9 It is placed in the underwear Figure 5 A view of the cooling device;

[0117] Figure 10 yes Figure 9 A side view of the cooling device; and

[0118] Figure 11 yes Figure 10 A top view of the cooling device. Detailed Implementation

[0119] Figures 1 to 4A wearable cooling device 10 for controlling the temperature of a male's testicles, embodied in this invention, is shown. The device includes a conduit consisting of conduits 12 and 14 for directing ambient airflow to an air delivery section 16, so that airflow is directed to the subject's genital area, in this case, the subject's scrotum. As further described below, with the fan 18 in operation, air is drawn from above the height of the trousers onto the upper ends 13 of each conduit 12 and 14, and the upper ends 13 of each conduit are shaped to hook onto the waistband of the trousers worn by the subject to hold the device in place. A perforated vent cap 15 is provided on the upper end of each of the conduits 12 and 14 to prevent debris from entering the conduit when the fan is running. Also shown, the conduits 12 and 14 are arranged at an angle to converge toward each other and open into the air delivery section 16 through a vent 20 in the conduit.

[0120] As will be understood, the term “ambient air” in this document refers generally to air from the atmosphere or the air present beneath the outer clothing or other garments worn by the user of a cooling device.

[0121] The fan 18 in the illustrated embodiment is a brushless axial fan and is housed in a motor housing 22, which forms part of the corresponding duct 12 or duct 14. As will be understood, other fan types may be used in embodiments according to the invention.

[0122] The air delivery section 16 of the device is cup-shaped and is fitted around the subject's scrotum, such as... Figures 2 to 3 Ideally, and when in the proper position, it bends beneath the subject's scrotum so that the scrotum lies within the curvature of the delivery section. A removable perforated filter 24 surrounds the interior of the air delivery section and allows airflow to contact the scrotum to achieve evaporative cooling and / or heat transfer to the surface of the scrotum during use of the device, thereby cooling the testicles. As will be understood, heat transfer to the scrotum can occur via convection as the air generated by the fan carries away the hot air in contact with the skin, and the faster the airflow, the greater the rate of convective heat transfer. Advantageously, in embodiments according to the invention, the cup-shaped profile of the air delivery section can enhance or facilitate convective heat transfer for achieving cooling.

[0123] The control module 26 is electrically connected to the fan 18 and the main temperature sensor 28 via a cable 29 of a certain length, allowing the control module to be located in an inner pocket or drawer of the subject's underwear or trousers. Alternatively, the cable may be long enough to allow the control module to be held in an outer pocket of the subject's trousers. The control module of the illustrated embodiment includes a power input port 34 for connecting an external power source (such as a power bank or other rechargeable power source) with a 5.1V DC 1A output to the control module for electrical operation of the device as described herein. Examples of suitable such low-voltage power sources that can be utilized include an external lithium-ion or nickel-cadmium power bank, or a battery with a storage capacity of 2200 mAh or higher, to enable the cooling device 10 to operate for extended periods. In other embodiments, the control module 26 may include an onboard rechargeable battery as a power source, with associated charging control circuitry for the battery.

[0124] In the illustrated embodiment, temperature sensor 28 is an infrared sensor mounted on a cup-shaped air delivery portion behind filter 24 so as to face the subject's scrotum for measuring the temperature of the scrotal skin surface. The temperature of the scrotum increases along the direction from the bottom of the scrotum to the neck, and in embodiments of the invention, the temperature sensor is typically arranged to measure the temperature of the central region of the scrotum, and most preferably, to measure the temperature along an imaginary midline between the bottom of the scrotum and the neck.

[0125] Additionally, in the illustrated embodiment, a further temperature sensor in the form of a thermistor, indicated by the numeral 30, is located on the central band 32 of the connecting tube arms 12 and 14. In use, the user inserts the device 10 into the underside of the front of their underwear, hooking the upper end 13 of the tube onto the waistband of their underwear to hold the device in place, with the air delivery portion covering the subject's scrotum. In this position, the thermistor 30 is located below the penis at the neck of the scrotum.

[0126] The control module 26 of the cooling device's control system houses a microcontroller programmed to perform automatic proportional-integral-derivative (PID) control of the operation of the DC motors of each fan 18 based on temperature data fed back from the temperature sensor 28. Each fan motor is equipped with an onboard motor driver, which, as is conventionally known, receives a low-current control signal from the microcontroller and powers the corresponding DC motor. In a particularly preferred embodiment, the operation of each motor is controlled via pulse-width modulation (PWM). The fans 18 can operate individually or in pairs. Typically, the fans 18 will operate in pairs in coordination, and in at least some embodiments, the operating speed of one fan may differ from that of the other. As will be understood, the microcontroller forms part of the device's control system, and the control system is operable to control the fan operation based on data output from the infrared temperature sensor 28.

[0127] In a preferred embodiment, the microcontroller is programmed to operate fan 18 to obtain a predetermined temperature measured by a temperature sensor. Typically, in embodiments used for cooling the scrotum, a predetermined temperature is selected to cool the testicles to a desired temperature level below the subject's core temperature, and / or to maintain the testicular temperature at a desired temperature level below the subject's core temperature. Human core temperature is generally considered to be 37°C, but in the general population, core temperature may vary between individuals between 36.1°C and 37.2°C, although individuals engaging in strenuous exercise may have higher core temperatures. In this embodiment, testicular cooling is achieved by allowing air to flow from the air delivery portion 16 of the device to the scrotum.

[0128] During operation, infrared temperature sensors 28 measure the surface temperature of the scrotum. The microcontroller then determines whether the input data from one or both of these temperature sensors is above or below a predetermined temperature. If data from one of the temperature sensors indicates that the measured temperature is above the predetermined temperature, the microcontroller signals the fan to operate, allowing air to flow through ducts to the scrotum to achieve evaporative cooling and / or heat transfer of the scrotal skin, thereby cooling the subject's testicles. When the temperature measured by one or both of the infrared sensors 28 drops to or below the predetermined temperature, the fan stops or its speed is reduced to maintain scrotal cooling and keep the measured temperature at or near the predetermined temperature. If the measured temperature of the scrotal surface (i.e., the skin) begins to rise above the predetermined temperature, the microcontroller signals the motor to start or increases the fan speed to increase the airflow to the scrotum, cooling it to the predetermined temperature. Repeat this process as needed to cool the surface of the scrotum to a predetermined temperature and / or maintain the measured scrotal temperature at a predetermined temperature, thereby cooling the temperature of the testicles to a desired level / temperature and / or maintaining the temperature of the testicles at a desired level / temperature.

[0129] Temperature data from the thermistor 30 is fed to the microcontroller via an analog-to-digital converter in the control module 26. In some embodiments, the temperature measured by the thermistor can be used as a reference temperature for determining the speed of the fan 18, or as a backup system for controlling the fan in the event of a failure of the infrared temperature sensor 28 or its associated temperature measurement circuitry. In other embodiments, the thermistor 30 or other such additional temperature sensors may be omitted entirely. In embodiments that include additional such temperature sensors, thermocouples or other infrared or other temperature sensing devices or arrangements may be used instead of the thermistors.

[0130] In summary, the operation of the fan used to cool the scrotum can be continuous or intermittent, and / or at full speed or reduced speed. This applies to the initial cooling of the scrotum to achieve a predetermined temperature, and to fan operation to maintain that predetermined temperature. Depending on the desired cooling rate or as determined by the microprocessor, the reduced speed can be 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the full speed of the corresponding fan motor. Furthermore, only one fan can be running at any given time, or one fan can operate at a different speed than the other. By reducing the fan speed and / or selectively operating one fan relative to the other, battery power in the control module can be saved, thereby extending the operating time.

[0131] Users can manually turn the device 10 according to the invention on and off by operating a switch located on the control module 26. In its most basic sense, embodiments according to the invention can be provided in which a cooling device without temperature and humidity sensors is provided. In this type of device, when the user manually turns on the device, the fan can run at a constant speed until the device is manually turned off. In such embodiments, the control system of the device may, for example, consist only of the switch itself and the associated wiring.

[0132] In a particularly preferred embodiment, the operation of the device can be controlled via a software application (app) installed on a portable electronic device (such as a smartphone), which connects wirelessly to the cooling device 10 of the present invention, most commonly via Bluetooth. TM Connection, but except for Bluetooth TM In addition to Bluetooth SIG, Inc., Kirkland, Washington, USA, other suitable systems conventionally known for enabling personal wireless connectivity with device 10 may be utilized. In the currently described embodiment, the control system of device 10 includes Bluetooth. TM The module interfaces with the microcontroller of the control module 26.

[0133] In at least some embodiments, the application may allow a user to wirelessly set a predetermined temperature or temperature range to operate the device, and for example, allow the user to turn the device on and off; set a specific predetermined temperature or temperature range to make the device operate automatically; and / or monitor one or more parameters, which may be selected from ambient air temperature, currently measured temperature of the genital area, or, in the case of a male, surface temperature of the scrotum or estimated temperature of the testes, changes in measured temperature over time, current usage duration of the device, power level of the device, remaining available usage time, setting of a timer for the device's operation, and / or remaining or elapsed time of the timer. The application may also include a usage log, allowing the user / subject to view relevant usage data, such as measured temperature and changes in measured temperature over time, as well as usage time and date, and all such combinations and permutations of the above functions are explicitly covered.

[0134] Although the specific embodiments described herein are based on the use of male subjects, embodiments of the invention may also be used by women to increase comfort in the genital area during exercise or for any reason that wearing the device as described herein may be helpful.

[0135] The device described herein can be used to reduce the temperature of the genital area by 1°C to 1.5°C or higher, such as 1.5°C, 2°C, 2.5°C, 3°C, 3.5°C, 4°C, 4.5°C, or 5°C or more.

[0136] The predetermined temperature reached by the fan of this device will typically be approximately 36°C, 35.5°C, 35°C, 34.5°C, 34°C, 33.5°C, 33°C, 32.5°C, 32°C, 31.5°C, 31°C, 30.5°C, 30°C, 29°C, 28°C, 27°C, 26°C, or approximately 25°C or lower. In embodiments, the predetermined temperature may be a discrete temperature or temperature range, such as from approximately 36°C, 35°C, or 34°C to approximately 25°C or lower, or any temperature or temperature range in between.

[0137] When a man wears the device for the treatment or prevention of fertility, infertility, or for fertility-related purposes as described herein, the device is typically operated to lower the temperature of the testicles by 1 degree or more, to below the subject's core body temperature, and preferably to a temperature in the range of about 2°C to 6°C below the subject's core body temperature, preferably in the range of about 36°C to about 32°C, 31.5°C, 31°C, 30.5°C, or 30°C or lower, and most preferably in the range of about 34.5°C to 33.5°C, for example, about 34°C. Typically, as described herein, the device embodied in this invention is operated to lower the measured temperature of the skin / surface of the subject's scrotum to a predetermined temperature for fertility-related purposes, the predetermined temperature ranging from about 36°C to 33°C, 31°C, or 30°C, 35.5°C to about 30°C, more typically in the range of about 35.5°C to about 32°C, and most typically in the range of about 35°C to about 33°C, for example, about 34°C.

[0138] The illustrated embodiment of device 10 described above is provided with converging conduits 12 and 14. However, in other embodiments, the device according to the invention can have different duct configurations for directing airflow to the air delivery portion of the device. For example, the duct may include a generally “T”-shaped configuration, wherein a duct oriented generally horizontally at its top opens at its opposite ends to draw in ambient air, and intersects with a downwardly directed duct portion in its middle region to direct airflow to the air delivery portion as described above. In this case, the top duct may be slightly curved in the horizontal plane to conform to the contour of the user's waist region, and a fan may be provided, for example, in the downwardly directed duct to draw air into the duct. In another embodiment, the duct may consist only of a downwardly directed duct (“I”-shaped duct configuration) so that, in use, the air drawn into the duct flows downward to the air delivery portion, also under the action of a fan provided in the lower duct. Thus, various duct configurations are possible, and all duct configurations are explicitly provided herein. In such devices, the tube may also be configured to hook onto the top of trousers, or the device may otherwise be provided with hooks or other means for hooking onto or adapting to the top of trousers or other clothing worn by the user to help keep the device in place. However, any other suitable system for keeping the device in place may be used, including, for example, the use of a belt or strap.

[0139] As will also be understood, embodiments may be provided in which the ambient air flowing from the fan to the genital area may originate from below the genital area rather than above the height of the pants.

[0140] In other embodiments according to this disclosure, embodiments of the invention are also used to direct airflow from the groin level to the genital area outside of underwear (e.g., briefs), under which the user wears the cooling device. Examples of this type of embodiment are shown in Figures 5 to 11 It is displayed in the middle.

[0141] like Figure 5 As shown, the cooling device 36 in this embodiment also includes a pair of fans 18 for directing air through ducts 12 and 14 into the interior of the cup-shaped air delivery section 16 from the duct's ventilation outlet 20, to flow over the genital area to be cooled; in this example, the genital area is also the male user's scrotum. However, in this embodiment, the air is drawn in from below the user's trousers or other outer clothing, rather than from above the trousers / waistline, as further described below. Figures 8 to 11 As shown. Therefore, with Figures 1 to 4 Compared to the illustrated embodiment, the conduits 12 and 14 in this embodiment are significantly shortened. Each fan 18 is also mounted externally to the inlet end of the corresponding conduit 12 or 14, rather than being located inside the conduit as in the embodiments described above. More specifically, in this embodiment, each fan 18 is mounted in a corresponding fan housing 38, which is fastened by fasteners to a corresponding support frame 40 integrally formed with the conduit 12 or 14. In the specific embodiment shown, instead of using infrared sensors for monitoring the surface temperature of the scrotum / genital area as in the embodiments described above, environmental sensors for measuring the temperature and relative humidity around the scrotum / genital area are used, and the operation of the fans is also controlled by data output from the environmental sensors as described herein to cool the surface of the scrotum / genital area. In the illustrated embodiment, the sensor (not shown) is located in a cavity 42 formed on the inner surface of the cup-shaped air delivery portion 16 of the device.

[0142] Environmental sensors in such embodiments may include, for example, a capacitive humidity sensor for measuring relative humidity and a thermistor, such as a negative temperature coefficient (NTC) thermistor, wherein the resistance change of the thermistor is used to determine the ambient temperature around the genital area / scrotum. Such environmental sensors available in the embodiments described herein include commercially available DHT11 sensors (e.g., Mouser Electronics, Inc., Mansfield, TX 76063-1514, USA), which contain an 8-bit microcontroller and are configured to output calibrated digital values ​​of temperature and relative humidity as serial data, wherein the calibration coefficients are stored in a one-time programmable (OTP) memory. For example, a DHT11 sensor is capable of measuring relative humidity in the range of 20% to 90% and temperature in the range of 0°C to 50°C. Other suitable environmental sensors including humidity and temperature sensor components may also be utilized in the embodiments described herein. In other embodiments, a separate sensor for measuring temperature and relative humidity may be employed, rather than a single component including both types of sensors as described above.

[0143] The cooling device 36 is connected via cable 29 to the control module 26 and the power source (e.g., a rechargeable battery pack) 44, but in other embodiments, the power source may be integrated into a power source such as... Figure 1 The control module in the embodiment shown. (And...) Figures 1 to 4 The embodiments shown are the same. Figure 5 The device is controlled via an application installed on the portable electronic device, which is typically connected wirelessly (such as, but not limited to, Bluetooth). TM smartphones, to be compatible with Figures 1 to 4 The illustrated embodiment provides functionality via an application, including displaying the current temperature and / or relative humidity of the genital area as measured by the device's environmental sensors.

[0144] Relative humidity measurement can provide a measure of comfort and can also be used as a means of assessing the risk of heat stress affecting male spermatogenesis and / or sperm motility or survival. In the embodiments described herein, the relative humidity measured by the environmental sensor can be used to control the operation of one or both fans 18 independently of the measured temperature or in combination with the temperature measured via the device's control system. Similarly, one or both fans 18 can be operated based on the temperature measured by the environmental sensor, independent of the relative humidity data output by the sensor. In the embodiments described herein, the user can select a fan operation mode from a variety of different modes to provide different possibilities as described above.

[0145] In a particularly preferred embodiment, the operation of fan 18 is controlled via a microcontroller of control module 26 using a reference temperature and humidity index (THI) to optimize cooling of the environment surrounding the genital area or scrotum. For example, if the temperature sensor assembly of the ambient sensor measures a given temperature of 34°C and the relative humidity sensor measures a relative humidity below 30%, the fan can operate at 10% to 30% of its maximum power to cool the genital area / scrotum to a predetermined temperature. Similarly, if the relative humidity measured at that temperature is 40% to 60%, fan 18 can operate at 40% to 80% of its maximum power, and if the measured relative humidity is 70% or higher, fan 18 can operate at maximum power / speed. As the measured temperature cools, the fan speed can also be gradually reduced or stopped by the microcontroller of the control system of control module 26, depending on the temperature measured by the ambient sensor (or, in the case of using separate temperature and humidity sensor assemblies). As will be understood, as the measured temperature decreases, the fan can also operate at a slower speed proportional to the relative humidity measured at a lower given temperature, and all such arrangements are explicitly provided in this document.

[0146] Additionally, the cooling device according to this disclosure may include only a single electric cooling fan 18, rather than a pair of fans 18 as shown in the currently illustrated embodiment.

[0147] The conduit of the device embodied in this invention is typically made of a sufficiently elastic plastic or silicone material to allow the conduit to bend and flex during use while keeping the conduit opening open, and may be reinforced with springs, ribs, and / or corrugated structures for this purpose. The air delivery portion 16 may be made of a softer and more flexible plastic material to provide comfort to the subject when wearing the device, for example, for fertility-related purposes such as treating or preventing infertility or low fertility, or increasing sperm count, or improving sperm motility or semen quality, or reducing sperm DNA breakage that may be increased due to prolonged exposure to elevated scrotal temperatures. In other embodiments of wearing the device during sports activities such as cricket, baseball, or hockey, the air delivery portion 16 of the device as described herein may be configured in at least some embodiments to cover the entire genital area of ​​the subject (i.e., in the case of a male, the penis and scrotum) and made of a rigid plastic material to protect the subject from impact injuries to the genital area. In such embodiments, the conduit may be formed of an elastic plastic material to allow the conduit to bend during the user's movement. In other embodiments, the device according to the invention may be incorporated into a conventional type of genital protector as part of the device.

[0148] In other embodiments, the device as described herein may be placed or worn within underwear or other types of lingerie to help hold the device in a position above the subject's genital area. In some embodiments, the underwear or lingerie may include an inner pocket for receiving the device when it is inserted into the front of the lingerie while worn. In such embodiments, the pocket may include a fabric or other wearable mesh separating layer to isolate the air delivery portion of the device from the genital area, while allowing the main temperature measuring sensor 28 to measure the temperature of the genital area within the line of sight, in the case of an infrared-type temperature sensor. In other embodiments, the lingerie worn by the subject may be attached to the device itself by any suitable means or method.

[0149] In a particularly preferred embodiment, Figure 5 The cooling device 36 shown can be combined with underwear or other types of lingerie, such as... Figures 9 to 11 As shown, the air delivery portion 16 of the device is located within the underwear (in this example, panties 46), with a fan exposed outside the underwear at groin height to allow air present beneath the user's pants (or, for example, shorts) to flow through conduits 12 and 14 of the device to contact the user's genital area / scrotum (if applicable). In the illustrated embodiment, the fan housing is mounted via a corresponding stretchable opening in the underwear, but any other suitable arrangement may be used to draw in ambient air present outside the underwear at groin height from beneath the user's pants or other outerwear. As will be understood, the opening protruding from the fan housing 38 may be resilient to aid in inserting the fan housing into the opening and holding the device in place. A belt and / or waistband may also be adapted to the cooling device to be worn around the user's waist and / or upper thighs to help hold the device in place.

[0150] The length of the cable 29 connecting the cup-shaped air delivery section 16 to the control module 26 (and the power supply, which is separate from the control module 26) allows the control module (and the power supply) to be located in one or more pockets of the user's trousers or shorts.

[0151] In another embodiment, the cooling device as described herein can be configured to receive a removable data storage device (e.g., a removable memory card, such as a Secure Digital (SD) card or Multimedia Card (MMC)) for recording data generated using the device as described above, so as to later remove the data storage device and download the data from the storage device for viewing on an external digital device (e.g., a computer). In a particularly preferred embodiment, the control module 26 may be provided with a port for inserting a removable data storage device to record data on the storage device.

[0152] In a further embodiment, the cooling device according to this disclosure can be configured such that the fan of the device can be turned on or off as needed by manually operating a switch located on the control module 26. That is, an embodiment can be provided that is completely free of any temperature sensor for measuring the temperature of the genital area, and once turned on, the fan will run until it is turned off by the user via an operating switch or through the application described above. Furthermore, in embodiments, the fan can operate at any speed, up to full speed, as needed or selected by the user.

[0153] In yet another embodiment, the cooling device may operate in one or more modes selected by the user, such as a continuous mode without a current temperature, in which the fan speed is preset or can be set by the user, and other modes in which the user can set a predetermined temperature and the device operates automatically in response to the temperature measured by a temperature sensor (and a humidity sensor, if set), as described herein.

[0154] Additionally, as described above, embodiments of the cooling device according to this disclosure can be configured to have at least one temperature sensor measure the temperature near the genital region, such as the near-ambient temperature rather than the surface temperature of the genital region, or a combination of the temperature near the genital region and the surface temperature of the genital region, and the device's fan operates based on the measured temperature. In embodiments measuring the ambient temperature near the genital region, the measured temperature can provide an indicative temperature of the genital region, and the device's fan can be operated accordingly. In embodiments, the measured ambient temperature can be the temperature between the air delivery section 16 and the genital region. At least one temperature sensor, or such embodiments, can be a thermistor or other suitable temperature sensor, such as an environmental sensor including a suitable temperature sensor for this purpose.

[0155] It should also be understood that the control module 26 can implement any suitable processing unit for processing relevant sensor data / messages, and may include a microprocessor, microcontroller, programmable logic device or other computing device, general-purpose computer or server computer.

[0156] Furthermore, the various aspects described herein can be implemented via any appropriate number and / or type of computer platform, module, processor, memory, etc., each of which can be embodied in hardware, software, firmware, middleware, etc.

[0157] Although the invention has been described above in the context of regulating the temperature of the testes of human males, the invention is not limited thereto, and embodiments are extended to provide and use appropriately configured devices, as described herein, for any male animal with a scrotum, such as equines (e.g., thoroughbred racehorses), camels, or bovids, sheep, pigs, felines, canines, or primates.

[0158] It is evident from the above description that the apparatus or method according to the invention can provide one or more advantages selected from the following:

[0159] The device is easy to use and operate;

[0160] • Automatic temperature control of the genital area cooled by the device;

[0161] • The fan operates intermittently to extend battery life, and thus extend runtime;

[0162] • Set the preset temperature and relative humidity to control the operation of the fan;

[0163] • The cooling device can be remotely controlled via an application on a portable electronic device, and operating variables, parameters, and usage data can be displayed on the electronic device;

[0164] • Use the device independently while working, exercising, or engaging in other activities;

[0165] • In at least some embodiments, the device is configured to help keep the device in place by hooking it onto the waist of the pants worn by the subject;

[0166] • Avoid using cooling bags / ice packs for cooling; and

[0167] Equally important, it can treat or prevent infertility, low fertility, increase sperm count, reduce abnormal sperm morphology, improve progressiveness or other sperm motility, reduce sperm DNA breaks, improve sperm viability and / or improve semen and / or seminal plasma quality.

[0168] Although several embodiments of the present invention have been described above, it should be understood that various modifications and changes can be made thereto without departing from the present invention. Therefore, the above embodiments are illustrative only and should not be considered as limiting or restrictive.

Claims

1. A wearable cooling device for regulating the temperature of a genital area of a subject, the device comprising: an air delivery portion configured for fitting around the genital area; and at least one electrically powered fan arranged for causing air flow to the air delivery portion by operation of the fan, to contact the genital area, to cool the genital area.

2. The cooling device of claim 1, wherein the at least one fan is arranged for causing the air to flow from outside an undergarment into the genital area of the subject who wears the device in the undergarment when using the cooling device.

3. The cooling device of claim 1 or 2, further comprising a duct for directing air flow from the at least one fan to the air delivery portion, the duct opening into the air delivery portion to cause the air flow to contact the genital area.

4. The cooling device of claim 3, wherein the at least one fan is arranged in the duct of the device to cause the air to flow through the duct into the air delivery portion.

5. The cooling device of claim 3, wherein the at least one fan is mounted outside the duct to cause the air to flow through the duct into the air delivery portion to contact the genital area.

6. The cooling device of claim 3, wherein the device is configured to draw the air from above the waist of the subject by operation of the at least one fan to cause the air flow to the air delivery portion to contact the genital area.

7. The cooling device of claim 4, wherein the device is configured to draw air from the groin of the subject outside an undergarment worn by the subject by operation of the at least one fan to cause the air flow to the delivery portion to contact the genital area.

8. The cooling device of any one of claims 2 to 7, comprising a pair of conduits and a pair of fans, one of the fans being arranged to cause the air to flow through a respective one of the conduits.

9. The cooling device of any one of claims 1 to 8, wherein the air is ambient air.

10. The cooling device of any one of claims 1 to 9, wherein the air delivery portion is shaped to cup the genital area of the subject when the subject wears the device.

11. The cooling device of any one of claims 1 to 10, further comprising a control system operable to control the operation of the fan.

12. The cooling device of claim 11, further comprising at least one temperature sensor for measuring the temperature of the genital area or in the vicinity thereof, and wherein the control system is operable to control the operation of the at least one fan in response to the temperature measured by the at least one temperature sensor.

13. The cooling device of claim 12, wherein the at least one temperature sensor is for measuring a surface temperature of the genital area.

14. The cooling device of claim 12, wherein the at least one temperature sensor is for measuring a temperature in the vicinity of the genital area.

15. The cooling device of claim 13 or 14, further comprising a humidity sensor for measuring a humidity in the vicinity of the genital area, and wherein the at least one fan is operable to initiate or increase the flow of air to the genital area in response to the temperature measured by the temperature sensor, and wherein the speed of the fan is controlled by the control system in relation to the humidity measured by the humidity sensor.

16. The cooling device of claim 15, wherein the humidity sensor is for measuring relative humidity.

17. The cooling device of any one of claims 12 to 14, wherein the at least one fan is operable to initiate or increase the flow of air to the genital area when the temperature measured by the at least one temperature sensor is above a predetermined temperature, and to decrease or stop the flow of air to the genital area when the measured temperature decreases or the measured temperature approaches, reaches or falls below the predetermined temperature.

18. The cooling device of claim 15 or 16, wherein the at least one fan is operable to initiate or increase the flow of air to the genital area when the temperature measured by the at least one temperature sensor is above a predetermined temperature.

19. The cooling device of claim 17 or 18, wherein the control system is operable to decrease or stop the flow of air to the genital area when the measured temperature decreases or the measured temperature approaches, reaches or falls below the predetermined temperature.

20. The cooling device of any one of claims 16 to 19, wherein the subject is a male and the genital area is the scrotum of the subject, and wherein the predetermined temperature is a temperature for cooling the temperature of a testicle below the core body temperature of the subject and / or maintaining the temperature of a testicle below the core body temperature of the subject.

21. The cooling device of claim 20, wherein the predetermined temperature is a temperature for cooling the temperature of the testicle to the core body temperature of the subject and / or maintaining the temperature of the testicle about 1 °C or more below the core body temperature of the subject.

22. The cooling device of any one of claims 17 to 21, wherein the predetermined temperature is a temperature within a predetermined temperature range.

23. The cooling device of claim 22, wherein the predetermined temperature range is about 29 °C to about 35 °C, inclusive.

24. The cooling device of any one of claims 11 to 23, wherein the control system of the cooling device comprises a microcontroller for controlling the operation of the at least one fan in response to the temperature measured by the at least one temperature sensor.

25. The cooling device of claim 15 or 16, wherein the control system of the cooling device comprises a microcontroller for controlling the operation of the at least one fan based on the temperature measured by the temperature sensor and / or the humidity measured by the humidity sensor.

26. The cooling device of any one of claims 1 to 19, wherein the subject is a male and the genital area is the scrotum of the subject.

27. A wearable cooling device for regulating the temperature of an external genital area of a subject, the device comprising: an air delivery portion for fitting around the genital area for delivering a flow of air into contact with the genital area to cool the genital area by air in contact with the genital area; at least one electrically powered fan arranged for causing the flow of air to the air delivery portion by operation of the fan; and a control system operable to control the operation of the fan.

28. A wearable cooling device for regulating the temperature of an external genital area of a subject, the device comprising: a duct for directing a flow of air to the genital area; at least one electrically powered fan arranged for causing the flow of air along the duct to contact the genital area by operation of the fan; and a control system operable to control the operation of the fan.

29. A wearable cooling device for regulating the temperature of an external genital area of a subject, the device comprising: at least one electrically powered fan arranged for causing a flow of air to contact the genital area by operation of the fan; at least one temperature sensor for measuring the temperature of or near the genital area; and a control system operable to control the operation of the fan in response to the temperature measured by the temperature sensor.

30. A wearable cooling device for regulating the temperature of a testicle of a male subject, the wearable cooling device comprising: a duct for directing a flow of air to the scrotum of the subject; at least one electrically powered fan arranged for causing the flow of air along the duct to contact the scrotum of the subject by operation of the fan; at least one temperature sensor for measuring the temperature of or near the scrotum; and a control system operable to control the operation of the fan. ​ ​ ​ a control system operable to control the operation of the fan in response to the temperature of the surface of the scrotum measured by the at least one temperature sensor when the subject is wearing the device.

31. A method for cooling the temperature of an external genital area of a subject, the method comprising: providing a wearable cooling device for the subject to wear to cool the genital area of the subject, the cooling device comprising: an air delivery portion for fitting around the genital area for delivering an air flow into contact with the genital area; at least one electrically powered fan arranged for causing the air flow to the air delivery portion by operation of the fan; and a control system operable to control the operation of the fan; fitting the device to the subject; and operating the control system of the device to operate the fan to cause the air flow to the air delivery portion when the subject is wearing the device.

32. A method for cooling the temperature of an external genital area of a subject, the method comprising: providing a wearable cooling device for the subject to wear to cool the genital area of the subject, the cooling device comprising: a duct for directing an air flow to the genital area; at least one electrically powered fan arranged for causing the air to flow along the duct into contact with the genital area by operation of the fan; and a control system operable to control the operation of the fan; fitting the device to the subject; and operating the control system of the device to operate the fan to cause the air flow to the genital area when the subject is wearing the device.

33. A method for regulating the temperature of an external genital area of a subject, the method comprising: providing a wearable cooling device for the subject to wear to cool the genital area of the subject, the cooling device comprising: at least one electrically powered fan arranged for causing an air flow into contact with the genital area by operation of the fan; at least one temperature sensor for measuring the temperature of the genital area or vicinity thereof; and a control system operable to control the operation of the fan in response to the temperature measured by the temperature sensor; fitting the device to the subject; and operating the control system of the device to control the operation of the fan in response to the temperature measured by the at least one temperature sensor when the subject is wearing the device.

34. A method for regulating the temperature of an external genital area of a subject, the method comprising: A wearable cooling device is provided for the subject to wear to cool the genital area of the subject, the cooling device comprising: a duct for directing a flow of air to the genital area; at least one electrically powered fan arranged for causing the air to flow along the duct into contact with the genital area by operation of the fan; at least one temperature sensor for measuring a temperature of the genital area or a vicinity thereof; and a control system operable to control the operation of the fan; fitting the device to the subject; and operating the control system of the device to control the operation of the fan in response to the temperature measured by the at least one temperature sensor while the subject is wearing the device.

35. The method of any one of claims 31 to 34, wherein the subject is a male and the genital area is a scrotum of the subject.

36. The method of claim 35, wherein the method is for regulating a temperature of a testicle of the subject.

37. A method for regulating a temperature of a testicle of a male subject, the method comprising: providing a wearable cooling device for the subject to wear to cool a surface temperature of a scrotum of the subject, the cooling device comprising: a duct for directing a flow of air to the scrotum; at least one electrically powered fan arranged for causing the air to flow along the duct into contact with the scrotum of the subject by operation of the fan; at least one temperature sensor for measuring the surface temperature of the scrotum; and a control system operable to control the operation of the fan; fitting the device to the subject; and operating the control system of the device to control the operation of the fan in response to the temperature of the surface of the scrotum measured by the at least one temperature sensor while the subject is wearing the device.

38. A method for regulating a temperature of a testicle of a male subject, the method comprising: fitting a wearable device to the subject for cooling a scrotum of the subject, the cooling device comprising: a duct for directing a flow of air to the scrotum; at least one electrically powered fan arranged for causing the air to flow along the duct into contact with the scrotum of the subject; at least one temperature sensor for measuring a temperature of the scrotum or a vicinity thereof; and a control system operable to control the operation of the fan; and operating the control system of the device to control the operation of the fan in response to the temperature measured by the at least one temperature sensor while the subject is wearing the device.

39. The method of any one of claims 36-38, wherein the method is used to modulate the temperature of the testes to achieve one or more outcomes selected from the group consisting of treating or preventing heat-induced infertility, subfertility, testicular hyperthermia, and / or sperm morphological abnormalities caused by testicular hyperthermia, treating or preventing sperm DNA fragmentation or DNA damage, increasing sperm count, improving or increasing sperm progressive motility, increasing sperm viability, and improving semen quality.

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